Kathmandu University School of Medical Sciences

Institutional Review Committee

(KUSMS-IRC)

Application for Ethical Approval of Research Proposal

(KUSMS-IRC)

INSTRUCTIONS TO THE INVESTIGATOR:

 Please read the instructions in italics carefully and complete all the sections (that implies to
your research). If a section is not applicable, mark NA.
 Type all the entries in English- Times New Roman Font, size 12 without bold/ Italics.
 Please complete all (A,B,C,D) in plain English
 Submit the completed application at KUSMS-IRC office, Dhulikhel Hospital.
 As you are writing the protocol, remove all instructions in italics (including
these) so that they are not contained in the final version.

Contact: KUSMS, Dhulikhel, P.O. Box: 11008, Nepal

Tel: 977-11-490497, Fax: 977-11-490707
Email: [email protected]
A. Research Proposal Information

A.1 Title of the study:

A.2 Research Proposal Version:

Type of submission  Initial review (first time submission)
 Revision according to IRC suggestions No. ……….
 Amendment No. ..….

A.3 Principal Investigator Name

 Faculty Staff (Go to A4.1)
 Student, ID/registration number ………………..… (select below and go to A4.2)
 Research for Thesis
 Ph.D./M.Phils./Fellowship  Masters In……………….
 Bachelor In:………………………..
 Other, specify ……………

 Other ………………………………………. (Please specify, and go to A4.1)

A.4 List name, affiliation and contact details of all investigator

A4.1 Faculty or Staff or other

Name Position Contact address E-mail address

Principal Investigator

Co-investigator
Co-investigator

A4.2 Students
Name Position Contact address E-mail address
Principal Investigator (preceptor)
Principal Investigator(student)

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A.5 Contact detail

(Give name, title, address, and contact details of the responsible investigator, or person who is taking
administrative responsibility for this study and can be contacted during the entire study.)

A.6 Nature of Study

 Clinical trial phase…/ Intervention study
 Bioequivalence/ pharmacokinetic drug study
 Epidemiological research
 Laboratory study
 Social/ behavioral research
 Study using stored specimens/tissue
 Study using stored medical records
 Others……………………………………………………………………………….....

A.7 Is study single center or multicenter

 Single center
 Multicenter (within Nepal)
Please specify the study sites ……………………………………………........
 Multicenter (International)
Please specify the study sites …………………………………........................
Note: NHRC Approval is compulsory for Ph. D/ International Study/ International
Collaboration/ Multicenter & Clinical Trial Study.

A.8 Summary of the proposed research protocol (within 200 words)

(The summary should be one paragraph and must include: A brief statement of the purpose,
objective(s), research methodology including research design, participants and procedures,
research setting, measurement tools and significance of the study)

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A.9 Source of Funding/Sponsor

 Funded by: ……………………………….(Please also specify funded year)

Budget amount: …………………………………...………………………..

 Expecting fund from: …………………

(State the name of the funding body and status of application)
Budget amount: …………………………………...………….…………….

A.11 Declaration of Co-I

(If PI or Co-PI have Conflict of Interest with the Institution/Company funding this project, please describe who has
the conflict, with what institution and how.)

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B. DETAIL OF THE STUDY

B.1. Background:
(Relevant to the topic, preferably recent evidences to drive the need of the study)

B.2. Statement of the problem/ rationale/ need of the study:

(Rationale should demonstrate the literature gap and what is intended to do to address the gap.
Describe why you are undertaking this study and why this study is needed, also include proper
in-text citation)

B.3. Research hypothesis (if applicable):

B.4. Objectives of the research:

General objective (s):
(Describe general purpose / objective (s) of the project)

Specific objective(s):
(Outline very specific objective(s) that will be met with this specific project)

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B.5. Study site and justification:
(Indicate where the sample (e.g., medical records or stored specimens) were obtained or the
data collection will take place. Give reasons for selecting the site. Permission letter from study
site is compulsory for proposal submission.))

B6. METHODS/ METHODOLOGY:

B.6.1 Research Methods (Cross in the appropriate box)

a) Qualitative Research b) Quantitative Research c) Mixed Research

Qualitative Research design (If applicable, Describe)

Quantitaitve Research Design (If applicable, Describe)

Mixed Research Design (If applicable, Describe)

B.6.2. Study design:

(Provide a description of type of study design. Experimental or observational: cohort, case
control or a cross sectional study)

B.6.3. Study Variables

(Provide a description of type of variables in study)

B.6.4. Expected outcomes of the research (Describe)

B.7 STUDY POPULATION AND SAMPLE

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B.7.1. Participants/ study population:
(Describe the participant characteristics whether healthy individuals, or patients from outpatient
department or hospital wards or community)

B.7.2 Selection criteria: (list out the criteria in bullets, provide reference if appropriate)

Inclusion criteria:
(Describe the specific criteria you will use to decide who will be included in your study from
among interested or potential subjects. Define any technical terms in lay language).

Exclusion criteria:
(Describe the specific criteria you will use to decide who will be excluded from your study from
subjects who meet the inclusion criteria listed above. Define any technical terms in lay
language).

B.7.3. Sampling method/ technique:

B.7.4. Sampling Unit:

B.7.5 Sample size determination:

(Mention appropriate number (neither too less nor too much) of participants (or participant
units) required for your study. Provide reference if your prediction of number is based on
previous studies. Include the calculation if you used formula to predict the sample size. Describe
procedure and information provide necessary references. (if any software is used to calculate
the sample size.)

B.8. Procedure:

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(Describe how participants will be screened/identified (by whom, where), how consent will be
obtained (who will take, how and where), how participants will be recruited (allocation,
randomization, grouping by matching, concealment etc), who will recruit and where, If blinded,
who (position of role, not name) will be blinded and how, Explain data collection steps very
clearly. In case of invasive techniques or interventions, explain the protocol concisely and
clearly. Expand information on use of drugs or device that is going to be used for the first time
(i.e. not yet approved for this purpose)

B.8.1. Data Collection Tools/ Measures:

(Include the list of data collection tools that will be used in the research including the
clinimetrics/ psychometric properties/ reliability and validity of the tools. If the tool is self-
designed, explain in brief how it was designed, and if pre-testing was done)

B.8.2. Pretesting

B.8.3. Validity and Reliability of tool

B.9. Plan for specimen/data management:

(Explain how the specimen/data will be managed, where will be the specimen/data be stored,
how will be the confidentiality of the specimen/ data maintained)

B.10. Plan for data analysis:

B.10. a. Software that will be used for data analysis:

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 B.10. b. Statistical tests: (Specify the most probable statistical tests that will be used to
analyze the data depending on the predicted nature of data)

B.11. Potential Biases

B.12. Limitations of the study (if any):

B.13. Plan for supervision and monitoring:

B.14. Plan for dissemination of the research:

B.15. DATA AND SPECIMEN BANKING AND/OR SHARING

B15.1 Management of specimen/data archiving or left-over

(If specimens will be kept after initial use, please specify the purpose for which they were
stored. Provide the duration of storage, and plan for discarding the specimens after use.
Always ask permission from the research participants to use their leftover specimens in
writing.)
(If data or specimens will be banked for future use, describe where the specimens/data will
be stored, how long they will be stored, when they will be destroyed (if ever), how the
specimens/data will be accessed, and who will have access to the specimens.)

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 (List the data to be stored or associated with each specimen.)

(Describe the procedures to release data or specimens, including: the process to request a
release, approvals required for release, who can obtain data or specimens, and the data to
be provided with specimens, including whether those data will be identifiable to others.)

B15.2 Specimen/data sharing plan

(Describe and/or attach data sharing plan according to the funding agency requirement.)
(If biological samples shall be transferred to or received from other institutions, please
attach a copy of Material Transfer Agreement.)

B16. Work plan (should include duration of study, tentative date of starting the project and
work schedule)

Work Duration/ Date Remarks

Protocol writing
Anticipated time of protocol approval
Clinical trial registry (in case of clinical trial)
Data collection and data entry
Data analysis
Manuscript/ thesis book preparation
Submission to journal/ dissemination

B17. BUDGET PLAN

(Include the details of anticipated budget for your research. Only few examples of the items
are listed, you may add up items based on the nature of your research. Please note that the
figures in the table are just examples)

SN Items Unit Unit cost Total

(NRs) (NRs)
1 Ethical clearance
2 Cost for printing/ photocopy
3 Allowance for participants
4 Laboratory cost
5 Payment to research assistant

Total

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C. ETHICAL CONSIDERATION
(Ethical principles are based on Declaration of Helsinki. Please refer to explanations of the
ethical consideration in the Declaration of Helsinki)

C1. SIGNIFICANCE OF THE STUDY

(Describe how this study is considered necessary, and reason why the study has to be carried out
by using human subjects)

C2. BALANCE OF RISK AND BENEFIT

C2.1 Risk of the study and Preventive and alleviative measures for risk

(List the reasonably foreseeable risks, discomforts, hazards, or inconveniences to the

participants related the participants’ participation in the research including nature and
degree of risks of possible injury, stress, discomforts, or invasion of privacy, and other side
effects from all study procedures, drugs and devices (standard and experimental), interviews
and questionnaires which may occur to the subject as a result of participating in the study.)

(If applicable, indicate which procedures may have risks to the participants that are
currently unforeseeable.)

(If applicable, describe risks to others who are not participants, e.g., risks to ethnic or
cultural groups, risks to sexual partners of participants, etc.)

(Describe prevention and treatment, medical care and other services to be provided to the
study participants who may or may not be affected by any complication)

C2.1. Risk management:

Potential risks identified Proposed measures to mitigate risks

1.

2.

3.

C2.3 Benefits of the study

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(Describe the anticipated benefits of this research for individual subjects in each subject group,
and society. If none, state “None.”)

C3. CONSIDERATION FOR VULNERABLE RESEARCH PARTICIPANTS

(The Committee would like to see evidence that the researcher recognizes the special needs of the
vulnerable groups (i.e., minors, prisoners, a person who is unable to make a decision, etc.) and
aware to reduce the possibility of damage to their rights and welfare. Please make sure that
proper informed consent process is performed.)

Check whether your study involves any of the following vulnerable research participants.
 Prisoners
 Pregnant women
 Mentally ill persons
 Cancer or terminally ill patients
 Neonates/infants/children (aged <18)
 HIV/AIDS patients
 Institutionalized persons e.g. military, students, etc.
 Others (please specify)………………………………….….
(If your study involves such individuals who are vulnerable to coercion or undue influence,
describe additional safeguards included to protect their rights and welfare)

C4. OBTAINING THE CONSENT:

C4. a. How will the informed consent be obtained from the research participants?

C4.b. Who will obtain the consent from the study participants?

C4. c. Is there anything being withheld from the research participants at the time the informed
consent is being sought? Mention “YES” or “NO
If yes, explain

C4.d Compensation for research participants

(If participants will receive payments, service, or any other incentive for participating,
provide details how much, and how it will be delivered to the subjects, for example, rated by
length of participation, at the end of the study, at the beginning of the study.)

 Yes, please provide details: ………………………………………………..………

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  No, please provide reasons: ………………………………………………..………

D. APPENDIX
D.1 REFERENCES
(Provide list of all references cited in the Submission Form using proper format, i.e. Vancouver style of
referencing.)

D.2 COMMITMENT AND SIGNATURE

Commitment from PI and Co-investigators
1.1 We, the principal investigator and co-investigators listed and signed below, certify that we
will adhere strictly to the information provided in the research proposal
1.2. We will report to the Ethics Committee any changes or any serious adverse effects that may
occur in this study.
1.3. We will notify research participants of any significant new findings developed during the
course of the study that may affect them and influence their willingness to continue
participation.
1.4. We will provide a progress report of the study annually, or as requested by the IRC.
1.5 We hereby certify that we will start our study only after the certification of approval by
KUSMS- IRC.

D2. Commitment from PI and Co-investigators

List the project team by filling in the table below. Add as many lines as needed. The percentage of time allocated to the
project must also be calculated. For example, on a 40-hour work week, working two hours five days a week is equivalent to
25% full-time equivalent (FTE).

First, Middle and Last Institution % of

Expertise Role in the Project Signature
Name Name FTE

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D.3 SUBMISSION PACKAGE SHOULD INCLUDES
No. Submitted Documents No. of Photocopy
1 Cover letter from Principal Investigator 1 original copy
2 Receipt of Submission Fee 1 photocopy
(Exempt for KU student’s projects )
3 Research Proposal Submission Form for a study 1 original

4 Full research protocol or main protocol (if applicable) 1

Informed Consent Form, Informed Assent Form, and
5 Participant information sheet (if applicable) 1
6 Case Record Form (if applicable) 1
7 1
Questionnaire/Proforma
8
Letter of permission from authorized person to use stored 1
  specimen/medical record (if applicable)
Letter of permission from authorized person of the implementing
9 institution for collaborative research/multisite research 1
10
For Students- approval letter from academic supervisor / advisor of the 1
concerned university
11 Letter of support from head or in-charge of the concerned department 1
in which the proposed study is being conducted.

12 1
Material Transfer Agreement (if applicable)
13 Investigator’s Brochure (if applicable) 1
14 CVs of all investigators (in brief not more than two pages) 1
15 List of abbreviations 1
16 1

17 1

D.4.Consent form:
Informed consent form (should be in English and also in the language of
participants)

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  Clear purpose of the research
 Procedure of the study
(Using lay language, explain what participants are supposed to do, time required,
setting/location, participants’ active or passive role, preparation for the research
participation etc., intervention or manipulation (if any), drug dosing information (if any))

 Voluntary participation
 Rights to withdraw from the study:
(A statement that the human participants can withdraw from the study at any time without
giving reason and without fear)

 Statement to assure confidentiality of the participant’s details.

 Risk and benefits of the participation
 Payment / compensation to the participants or their community (if any):
(Describe any payment you will provide, including total amount/value, when you pay to
them (at the beginning or end), describe if any non-monetary compensation eg: fuel for
transportation, lodging during data collection, will be provided).

 A statement indicating that the participants has understood all the

information in the consent form and is willing to volunteer / participate in
the research.
 Signature space for the research participants, a witness with the date.
Note- Informed consent form should be submitted in English language and in the
language appropriate to the research participants, example- Nepali.

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